Value of Urodynamics Prior to Stress Incontinence Surgery 2 (VUSIS 2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00814749
First received: December 24, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.


Condition Intervention
Stress Urinary Incontinence
Procedure: midureteral sling
Other: surgical therapy or conservative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Non inferiority of the improvement of the urinary distress inventory one year after treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cure of incontinence as measured with voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: November 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgical therapy Procedure: midureteral sling
midureteral sling
Active Comparator: individual management Other: surgical therapy or conservative
midureteral sling or conservative; medication, physiotherapy

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence
  • Signs of stress urinary incontinence on physical examination or voiding-diary
  • Patient is a candidate for surgical treatment (as based on history and physical examination)
  • Patient has attended at least 3 months of physiotherapy
  • Patient accepts randomisation
  • Patient is capable to fill out bladder diary's, pad tests and questionnaires
  • Patient understands the Dutch written and spoken language
  • ASA 1 or 2

Exclusion Criteria:

  • Previous incontinence surgery
  • Mixed urinary incontinence, urge component is predominant
  • Prolapse >= 1cm beyond the hymen on Valsalva in supine position
  • Postvoid urinary residual > 150ml
  • Present urinary tract infection
  • The need for additional pelvic surgery (prolapse and/or hysterectomy)
  • Patient is or wants to become pregnant
  • Prior pelvic radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814749

Contacts
Contact: Sanne van Leijsen, M.D. +31-6-41520114 sannevanleijsen@hotmail.com
Contact: Mark Vierhout, M.D. PhD +31243613635 m.vierhout@obgyn.umcn.nl

Locations
Netherlands
University Medical Center St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Sanne van Leijsen, MD    +31641520114    sannevanleijsen@hotmail.com   
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Mark Vierhout, MD, PhD Radboud University
Principal Investigator: John Heesakkers, MD, PhD University Medical Center St. Radboud
Principal Investigator: Kirsten Kluivers, MD, PhD University Medical Center St. Radboud
Principal Investigator: Sanne van Leijsen, MD University Medical Center St. Radboud
Principal Investigator: Ben Willem Mol, MD, PhD Academic Medical Centre Amsterdam
  More Information

Additional Information:
No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00814749     History of Changes
Other Study ID Numbers: 2006/197
Study First Received: December 24, 2008
Last Updated: December 24, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
stress urinary incontinence
urodynamics
randomized clinical trial
surgery

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014